Heart FailureRESPECTNCT04757246
RESPECT Heart Failure- RESpiratory Pattern Evaluation in Clinical Trials for HF
A study testing MouthLab Device in people with Heart Failure, run by WakeMed Health and Hospitals at 1 site in United States.
Trial summary
The goal is to evaluate the trends in MouthLab parameters (respiration rate, temperature, pulse rate, electrocardiogram rhythm, blood pressure, oxygen saturation heart rate and basic lung function measures) in patients with decompensated heart failure and how these measurements change in response to decongestion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- MouthLab Device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2022to 20 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 18 years old
- Willing and able to provide informed consent
- Admitted within previous 24 hours with HF exacerbation requiring intravenous diuretic therapy (reduced or preserved ejection fraction)
- English speaking
- Adults aged ≥ 18 years old
- Willing and able to provide informed consent
Show all 11Show fewer
- Patients presenting to the clinic and not being admitted to the hospital, who have been admitted for a HF exacerbation within the past 6 months, OR patients being discharged from a HF exacerbation related inpatient hospitalization
- For inclusion in Cohort 2, patients must have Boston Scientific pacemaker or defibrillator with Heart Logic capability
- For inclusion in Cohort 3, patients must have implantable CardioMEMS device
- Patients currently on inotropes
- English speaking
Who cannot join
- Currently on dialysis
- Patients with acute coronary syndrome
- Currently on hospice
- Have a heart transplant or left ventricular assist device
- Outpatient Sub-Study Eligibility Criteria
- Currently on dialysis
- Currently on hospice
- Have a heart transplant or left ventricular assist device
Trial locations and contacts
1 site in 1 country.
United States1 site
WakeMed Health and Hospitals
Raleigh, North Carolina, 27610
About this study
The goal is to evaluate the trends in MouthLab parameters (respiration rate, temperature, pulse rate, electrocardiogram rhythm, blood pressure, oxygen saturation heart rate and basic lung function measures) in patients with decompensated heart failure and how these measurements change in response to decongestion. The research will test the ability of the MouthLab device to predict clinical decompensation in patients with known heart failure and to reduce the number of hospital readmissions based on the treatment guided by MouthLab device data.
Read the detailed description
Heart failure (HF) is becoming increasingly recognized with an estimated worldwide prevalence of >37.7 million individuals. In the United States alone, there are over 5 million patients with HF which is expected to increase to over 8 million by 2030. Despite advances in medical therapies and technology, HF remains the leading cause of hospitalization among adults and the elderly. By 2030, the medical costs of HF are expected to rise from $20.9 billion to $53.1 billion, with nearly 80% of the projected increased expenses attributes to hospitalization costs. As such, it is imperative to develop new technologies and treatment options to impact the HF epidemic.
The majority of HF hospital admissions are due to volume overload. Stiffened and/or weakened myocardium predisposes patients to the accumulation of extracellular fluid resulting in increased intracardiac filling pressures and symptoms of congestion (edema, dyspnea and orthopnea). Accurate assessment of a patient's volume status remains clinically challenging at times. While there have been technological advances in the outpatient monitoring of volume status through thoracic impedance and pulmonary artery pressure monitoring, there are no validated, non-implantable options for monitoring volume status outside of the physical exam.
Aidar Health's MouthLab device is a non-invasive, hand-held, home monitoring tool that measures multiple medical parameters such as - Temperature, Blood Pressure, Heart Rate, Heart Rate Variability, Pulse Rate, SpO2, single-lead ECG, Respiratory Rate, Breathing Pattern/Respiratory Flow Cycle Morphology, and basic lung functions (FEV1, FVC, FEV1/FVC, PEF) in 30 seconds.
The investigators believe that the MouthLab device holds the potential to identify changes in volume status through measurements such as pulse rate, oxygen saturation, respiratory flow and lung function and accurately predict decompensation in patients with chronic HF. The investigators propose the following outline of clinical studies to evaluate the utility of the MouthLab device in HF.
- Conditions
- Heart Failure
- Being tested
- MouthLab Device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MouthLab DeviceOther
Use of MouthLab system
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Stable outpatients without implantable devices Receives: Other: MouthLab Device |
| Cohort 2 | Other | Stable outpatients with Boston Scientific pacemakers or defibrillators with Heart Logic capability Receives: Other: MouthLab Device |
| Cohort 3 | Other | Stable outpatients with implantable CardioMEMS devices Receives: Other: MouthLab Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate trends of respiration rate per minute
Respiration rate measured by breaths taken per minute
Measured: 6 months
Aidar Questionnaire to Evaluate Patient Perception of Heart Failure
The Aidar Questionnaire will be used to determine patient perception of severity of heart failure.
Measured: 6 months
Evaluate trends of temperature measured in Fahrenheit
Temperature
Measured: 6 months
Evaluate trends of pulse rate per minute
Pulse rate
Measured: 6 month
Evaluating the P wave of electrocardiogram in milliseconds
P wave on electrocardiogram will be measured to determine heart rhythm
Measured: 6 months
Evaluating the QRS complex on electrocardiogram in milliseconds
QRS complex will be measured to determine heart rhythm
Measured: 6 months
Evaluating the T wave on electrocardiogram in milliseconds
T wave will be measured to determine heart rhythm
Measured: 6 months
Evaluate trends of blood pressure measured in mm/Hg
Blood pressure
Measured: 6 months
Evaluate trends of blood oxygen saturation (SpO2) in percentage
blood oxygen saturation (SpO2)
Measured: 6 months
Measuring FEV1 (Forced Expiratory Volume) in Liters
Determining Lung Function
Measured: 6 months
Measuring FVC (Forced Vital Capacity) in Liters
Determining Lung Function
Measured: 6 months
Measuring FEV1/FVC as a ratio
Determining Lung Function
Measured: 6 months
Measuring PEF (Peak Expiratory Flow) in Liters/second
Determining Lung Function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study startOct 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completion20 Oct 2022
Why it stopped: Funding from Sponsor did not come through
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- WakeMed Health and Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Russell, M.D., WakeMed Health and Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757246
- Sponsor's protocol ID
- 1705978
- Acronym
- RESPECT
- Status last verified
- Oct 2022
- First submitted
- 21 Jan 2021
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
PubMed 30700139Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
PubMed 26673558Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.
PubMed 23616602Felker GM, Ellison DH, Mullens W, Cox ZL, Testani JM. Diuretic Therapy for Patients With Heart Failure: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 17;75(10):1178-1195. doi: 10.1016/j.jacc.2019.12.059.
PubMed 32164892Guyatt GH, Nogradi S, Halcrow S, Singer J, Sullivan MJ, Fallen EL. Development and testing of a new measure of health status for clinical trials in heart failure. J Gen Intern Med. 1989 Mar-Apr;4(2):101-7. doi: 10.1007/BF02602348.
PubMed 2709167Garin O, Ferrer M, Pont A, Rue M, Kotzeva A, Wiklund I, Van Ganse E, Alonso J. Disease-specific health-related quality of life questionnaires for heart failure: a systematic review with meta-analyses. Qual Life Res. 2009 Feb;18(1):71-85. doi: 10.1007/s11136-008-9416-4. Epub 2008 Dec 4.
PubMed 19052916
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESPECT Heart Failure- RESpiratory Pattern Evaluation in Clinical Trials for HF
- ClinicalTrials.gov ID
- NCT04757246
- Acronym / sponsor ID
- RESPECT / 1705978
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding from Sponsor did not come through
- Enrolment
- 0 participants (actual)
- Lead sponsor
- WakeMed Health and HospitalsUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to evaluate the trends in MouthLab parameters (respiration rate, temperature, pulse rate, electrocardiogram rhythm, blood pressure, oxygen saturation heart rate and basic lung function measures) in patients with decompensated heart failure and how these measurements change in response to decongestion. The research will test the ability of the MouthLab device to predict clinical decompensation in patients with known heart failure and to reduce the number of hospital readmissions based on the treatment guided by MouthLab device data.
Detailed description
Heart failure (HF) is becoming increasingly recognized with an estimated worldwide prevalence of >37.7 million individuals. In the United States alone, there are over 5 million patients with HF which is expected to increase to over 8 million by 2030. Despite advances in medical therapies and technology, HF remains the leading cause of hospitalization among adults and the elderly. By 2030, the medical costs of HF are expected to rise from $20.9 billion to $53.1 billion, with nearly 80% of the projected increased expenses attributes to hospitalization costs. As such, it is imperative to develop new technologies and treatment options to impact the HF epidemic.
The majority of HF hospital admissions are due to volume overload. Stiffened and/or weakened myocardium predisposes patients to the accumulation of extracellular fluid resulting in increased intracardiac filling pressures and symptoms of congestion (edema, dyspnea and orthopnea). Accurate assessment of a patient's volume status remains clinically challenging at times. While there have been technological advances in the outpatient monitoring of volume status through thoracic impedance and pulmonary artery pressure monitoring, there are no validated, non-implantable options for monitoring volume status outside of the physical exam.
Aidar Health's MouthLab device is a non-invasive, hand-held, home monitoring tool that measures multiple medical parameters such as - Temperature, Blood Pressure, Heart Rate, Heart Rate Variability, Pulse Rate, SpO2, single-lead ECG, Respiratory Rate, Breathing Pattern/Respiratory Flow Cycle Morphology, and basic lung functions (FEV1, FVC, FEV1/FVC, PEF) in 30 seconds.
The investigators believe that the MouthLab device holds the potential to identify changes in volume status through measurements such as pulse rate, oxygen saturation, respiratory flow and lung function and accurately predict decompensation in patients with chronic HF. The investigators propose the following outline of clinical studies to evaluate the utility of the MouthLab device in HF.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Other: MouthLab DeviceStable outpatients without implantable devices |
| Cohort 2 | Other | Other: MouthLab DeviceStable outpatients with Boston Scientific pacemakers or defibrillators with Heart Logic capability |
| Cohort 3 | Other | Other: MouthLab DeviceStable outpatients with implantable CardioMEMS devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults aged ≥ 18 years old
- Willing and able to provide informed consent
- Admitted within previous 24 hours with HF exacerbation requiring intravenous diuretic therapy (reduced or preserved ejection fraction)
- English speaking
- Adults aged ≥ 18 years old
Key exclusion criteria (8 listed)
- Currently on dialysis
- Patients with acute coronary syndrome
- Currently on hospice
- Have a heart transplant or left ventricular assist device
- Currently on dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MouthLab DeviceUse of MouthLab system | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Evaluate trends of respiration rate per minute
Time frame: 6 months
Respiration rate measured by breaths taken per minute
Aidar Questionnaire to Evaluate Patient Perception of Heart Failure
Time frame: 6 months
The Aidar Questionnaire will be used to determine patient perception of severity of heart failure.
Evaluate trends of temperature measured in Fahrenheit
Time frame: 6 months
Temperature
Evaluate trends of pulse rate per minute
Time frame: 6 month
Pulse rate
Evaluating the P wave of electrocardiogram in milliseconds
Time frame: 6 months
P wave on electrocardiogram will be measured to determine heart rhythm
Evaluating the QRS complex on electrocardiogram in milliseconds
Time frame: 6 months
QRS complex will be measured to determine heart rhythm
Evaluating the T wave on electrocardiogram in milliseconds
Time frame: 6 months
T wave will be measured to determine heart rhythm
Evaluate trends of blood pressure measured in mm/Hg
Time frame: 6 months
Blood pressure
Evaluate trends of blood oxygen saturation (SpO2) in percentage
Time frame: 6 months
blood oxygen saturation (SpO2)
Measuring FEV1 (Forced Expiratory Volume) in Liters
Time frame: 6 months
Determining Lung Function
Measuring FVC (Forced Vital Capacity) in Liters
Time frame: 6 months
Determining Lung Function
Measuring FEV1/FVC as a ratio
Time frame: 6 months
Determining Lung Function
Measuring PEF (Peak Expiratory Flow) in Liters/second
Time frame: 6 months
Determining Lung Function
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Results publication: PubMed 30700139Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.
- Results publication: PubMed 26673558Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
- Results publication: PubMed 23616602Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.
- Results publication: PubMed 32164892Felker GM, Ellison DH, Mullens W, Cox ZL, Testani JM. Diuretic Therapy for Patients With Heart Failure: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 17;75(10):1178-1195. doi: 10.1016/j.jacc.2019.12.059.
- Results publication: PubMed 2709167Guyatt GH, Nogradi S, Halcrow S, Singer J, Sullivan MJ, Fallen EL. Development and testing of a new measure of health status for clinical trials in heart failure. J Gen Intern Med. 1989 Mar-Apr;4(2):101-7. doi: 10.1007/BF02602348.
- Results publication: PubMed 19052916Garin O, Ferrer M, Pont A, Rue M, Kotzeva A, Wiklund I, Van Ganse E, Alonso J. Disease-specific health-related quality of life questionnaires for heart failure: a systematic review with meta-analyses. Qual Life Res. 2009 Feb;18(1):71-85. doi: 10.1007/s11136-008-9416-4. Epub 2008 Dec 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MouthLab Device in people with Heart Failure, run by WakeMed Health and Hospitals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate trends of respiration rate per minute (time frame: 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04757246, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.